Skeletal fractures are common injuries. These fractures are typically debilitating and often require the patient to undergo surgery. Depending on the severity of the fracture, the orthopedic surgeon has several options for treatment, ranging from simple fracture reducing implants to complete prosthetic replacements. However, even when the treatment of the fracture does not call for a complicated procedure such as complete replacement, the proper setting of a fractured bone can still pose substantial challenges to even the most skilled orthopedic surgeon.
The difficulties that a surgeon has to deal with when reducing a fracture are well known. These difficulties include dealing with the shape and positioning of the bones or bone fragments when aligning the fracture and the accompanying complications regarding the proper placement of an orthopedic implant for supporting and holding the fracture in proper alignment until it heals. This latter problem of implant alignment still remains as one of the challenges facing an orthopedic surgeon in fracture surgery.
Fractures of long bones, such as the femur, are often treated with the use of an intramedullary rod (“IM rod”) inserted into the medullary canal of the affected bone. An IM rod, as is well known in the art, generally comprises an elongated rod along with associated cross-members such as screws, tacks or nails, including nails having helical blades. The IM rod typically includes various transverse holes to allow for the placement of the cross-members through the IM rod and into bone tissue in order to stabilize and hold together the fragmented bone segments. For example, in the treatment of fractures in the area of the neck and/or head of the femur, a lag screw or nail (with or without helical blades) can be inserted through the proximal portion of the IM rod, across the fracture, and then into the femoral head. For more distal shaft type fractures, locking screws, bolts or nails can be placed through the IM rod and into bone tissue at appropriate locations in order to provide fixation of the bone fragments.
Implanting IM rods generally involves the insertion of the rod into the medullary canal through a point located at the end of the bone. An osteotomy is made to create an entry site and a flexible reamer is utilized to carry out the reaming of the medullary canal while conforming to its basic anatomy. Once a suitable hole has been prepared, the IM rod is inserted through the entry site and into the medullary canal. However, the size and shape of the IM rod can make its insertion into the medullary canal difficult. As the IM rod may be smooth and may have a narrow diameter, the surgeon may not be able to achieve a tight grip on the rod in surgery. Furthermore, a large amount of force may be needed to push the rod into the medullary canal and the rod may also need to be rotated along its axis or otherwise maneuvered to assist in insertion, which can all make insertion difficult. In addition, the location of the individual holes of the rod must be identified in order to place cross-members through the rod while it is in place within the medullary canal.
A variety of insertion systems have been developed in order to facilitate orthopedic implant placement in bone fracture surgery. The use of such insertion systems have assisted orthopedic surgeons in aligning and implanting fixation implants to insure the proper healing of the fracture. For example, implant insertion handles are commonly used to align and hold the IM rod as it is inserted into the marrow canal of a fractured bone, and to connect to the other implant insertion instruments, such as an aiming arm. The handle member is a curved body which may have a bore located at a first end of the handle for coupling to a fixation implant and may have a plurality of bores located at a second end of the handle. The implant insertion handle provides the surgeon with a large grip that allows the application of a large amount of force to the IM rod, allows the rod to be easily manipulated or twisted, and can be utilized as an alignment reference for cross-members that must be inserted into the bone and through the IM rod.
However, while these implant insertion handles are useful in helping to insert an IM rod, their use requires a certain amount of preparation in the operating room prior to the insertion of the IM rod. Once an appropriately sized IM rod has been selected by the surgeon, the insertion handle must be properly aligned with an alignment indicator on the proximal end of the IM rod and while the components are being held in position, a connecting screw must be inserted through the handle and into the IM rod. The connecting screw is then tightened with a screwdriver or other suitable device while the components are being held in position.
Because the various components to be connected together can be somewhat unwieldy, oftentimes the surgeon or operating room technician will have difficulty aligning and holding the components together prior to tightening the connecting screw. As described above, attaching the handle to the IM rod requires that multiple pieces be held precisely in position at the same time that a tool is used to tighten the connecting screw. The difficulties inherent in assembling these components can result in the device being dropped on the floor, thereby affecting the sterility of the instruments. In addition, components may move out of alignment while the connecting screw is being tightened, resulting in the handle being out of alignment with the IM rod. This can result in an improperly placed intramedullary rod or the inability to locate transverse openings for the insertion of cross-members through the IM rod.